EP2836138A1 - Balloon dilation catheter system for treatment and irrigation of the sinuses - Google Patents
Balloon dilation catheter system for treatment and irrigation of the sinusesInfo
- Publication number
- EP2836138A1 EP2836138A1 EP13718974.2A EP13718974A EP2836138A1 EP 2836138 A1 EP2836138 A1 EP 2836138A1 EP 13718974 A EP13718974 A EP 13718974A EP 2836138 A1 EP2836138 A1 EP 2836138A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- guiding element
- balloon
- catheter
- sinus
- movement mechanism
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/24—Surgical instruments, devices or methods, e.g. tourniquets for use in the oral cavity, larynx, bronchial passages or nose; Tongue scrapers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/06—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0113—Mechanical advancing means, e.g. catheter dispensers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M25/09041—Mechanisms for insertion of guide wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1002—Balloon catheters characterised by balloon shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1018—Balloon inflating or inflation-control devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
- A61M29/02—Dilators made of swellable material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M3/00—Medical syringes, e.g. enemata; Irrigators
- A61M3/02—Enemata; Irrigators
- A61M3/0233—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M3/00—Medical syringes, e.g. enemata; Irrigators
- A61M3/02—Enemata; Irrigators
- A61M3/0233—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs
- A61M3/0254—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs the liquid being pumped
- A61M3/0258—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs the liquid being pumped by means of electric pumps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M3/00—Medical syringes, e.g. enemata; Irrigators
- A61M3/02—Enemata; Irrigators
- A61M3/0279—Cannula; Nozzles; Tips; their connection means
- A61M3/0295—Cannula; Nozzles; Tips; their connection means with inflatable balloon
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/24—Surgical instruments, devices or methods, e.g. tourniquets for use in the oral cavity, larynx, bronchial passages or nose; Tongue scrapers
- A61B2017/246—Surgical instruments, devices or methods, e.g. tourniquets for use in the oral cavity, larynx, bronchial passages or nose; Tongue scrapers for cleaning of the nose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M2025/0008—Catheters; Hollow probes having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1079—Balloon catheters with special features or adapted for special applications having radio-opaque markers in the region of the balloon
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1093—Balloon catheters with special features or adapted for special applications having particular tip characteristics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
- A61M2210/06—Head
- A61M2210/0681—Sinus (maxillaris)
Definitions
- the guiding element is selected from the group consisting of a sinus illumination system and a guide wire.
- the invention is a method for treating a target space in the nasal anatomy.
- the method includes inserting a medical device into the sinus anatomy, the medical device having a handle, a guiding element, a sinus guide catheter, a balloon dilation catheter having irrigation apertures, a balloon catheter movement mechanism and a guiding element movement mechanism.
- FIG. 6 is an enlarged cut-away view of the dual lumen to balloon transition of the catheter of FIG. 1.
- FIG. 9 is a side view of a medical device for the treatment of a sinus opening according to an embodiment of the present invention.
- FIG. 10 is an enlarged cut-away view of the integrated shaft system of another embodiment of the present invention.
- FIG. 10A is a cross section of the distal end of the embodiment shown in FIG. 10 and FIG. 10B is a cross-section of the proximal end of the embodiment shown in FIG. 10.
- FIG. 11 is an enlarged view of the proximal side of the guiding element movement mechanism and the balloon catheter movement mechanism according to one embodiment of the current invention.
- FIG. 12 is a top view of the medical device of a particular embodiment of the invention including the mechanisms of FIG. 11.
- FIG. 13 and FIG. 14 are side views of the medical devices of FIG. 12 with the guiding element movement mechanism in front of the balloon catheter movement mechanism (FIG. 13) and with the balloon catheter movement mechanism in front of the guiding element movement mechanism (FIG. 14).
- FIG. 15 is an enlarged cut-away view of alternative embodiment of the integrated shaft system of the present invention.
- FIG. 19A and FIG. 19B are cut-away views of alternative embodiment of the handle of the medical device of the invention.
- FIG. 20A is a side view of alternative embodiment of the handle of the medical device of the invention.
- FIG. 20B is a cut-away view of the handle of FIG. 20A.
- FIG. 21A is a side view of alternative embodiment of the handle of the medical device of the invention.
- FIG. 21B is a cut-away view of the handle of FIG. 21A.
- FIG. 23 is a side view of an alternative embodiment of the handle of the medical device of the invention.
- embodiments of the present invention is sufficiently stiff that it can be beneficially employed to access sinus anatomy followed by a convenient remodeling and irrigation of the sinus.
- the inflation lumen 108 is used for inflation of the balloon with water, contrast medium or saline through inflation port 160, and the guiding element lumen 110 permits passage of a guidewire or sinus illumination system to facilitate
- the balloon dilation catheter proximal section 124 comprises a luer connector 132 that has an inflation port 160, a balloon catheter movement mechanism 134 (see also FIG. 4) and inflation tubing 122.
- the inflation tubing 122 is a flexible material selected from Nylon or pebax of various durometers (including but not limited to 72D, 70D and 63D) or Hytrel.
- the luer connector 132 is bonded to the roughened or unroughened inflation tubing 122, such that the luer connector 132 can be attached to an inflation device (not shown), and can be flexibly moved away from the balloon dilation catheter 100 during a medical procedure.
- the proximal section 124 has a length of between about 100 mm to 400 mm, often about 320 mm.
- the middle section 114 of the shaft system 102 is shown in greater detail in FIGs. 3 and 5.
- the proximal end 140 of the middle section 114 has single lumen inflation tubing that is surrounded by a hypotube 116.
- Distal to the single lumen inflation tubing is a mid-catheter portion 144 (shown as Circle AB in FIG. 3 and in detail in FIG. 5).
- Mid-catheter portion 144 comprises a first single lumen inflation tubing section 142, a second single lumen inflation tubing section 143 and the hypotube 116, but also includes a cut-out portion146 of the hypotube 116 and a polymer jacket 150 (see FIG. 3) over the hypotube 116.
- Alternative embodiments contemplate the use of a metallic material for the polymer jacket, or for spring loading it such that it need not be affixed to the guiding element movement mechanism 608 or for using a loosely wound spring coil around the cut-out portion 146 of the hypotube 116 that is compressed as the guiding element movement mechanism 608 is moved distally down the handle 614.
- the middle section 114 of the balloon dilation catheter 100 includes a guiding element insertion port 112 (see FIG. 7A) where the guiding element lumen 110 begins.
- the guiding element lumen 110 and the inflation lumen 108 are side by side lumens (see Circle AC of FIG. 3 and in detail in FIG. 7A and 7B) that extend from the distal end of the cut-out portion 146 of the hypotube 116 to the balloon transition section 148 shown as Circle AD in FIG. 3 and in detail in FIG. 6). Both the material of the middle section 114 and its dual lumen construction ensure its kink resistance during insertion and retraction of the balloon dilation catheter 100.
- the middle section 114 has a length of between about 70 mm and 110 mm, often about 90 mm.
- the shaft diameter is between about 1 and 3 mm, often about 2 mm.
- the overall length of the balloon dilation catheter 100 is between about 210 mm to about 610 mm, often about 540 mm.
- direct visualization markers and/or radiographic markers may be disposed along the integrated shaft system 102.
- direct visualization markers refers to markers that may be viewed during use with the naked eye or by use of an endoscope, while radiographic markers include radiopaque material and are viewed using a radiographic device such as intra-operative fluoroscopy.
- Direct visualization markers can be positioned in a number of locations along the integrated shaft system 102. Although one embodiment is described here with reference to FIGs. 1 and 2, other variations may be substituted in alternative embodiments.
- shaft system 102 may have a dark color, such as black, dark blue, dark grey or the like, and markers may have a light color, such as white, green, red or the like.
- markers may have different colors and/or different widths to facilitate distinguishing the markers from one another during use. This contrast in colors may facilitate viewing the markers in a darkened operation room and/or when using an endoscope inside a patient in the presence of blood.
- first distal shaft marker 128 there may be a first distal shaft marker 128 (or
- endoscopic marker since it is typically viewed during use via an endoscope (endoscopic marker), since it is typically viewed during use via an endoscope) disposed on the distal shaft portion 118 on the shaft system102 such that the distal edge of the marker is 1 cm. ⁇ .0.2 cm from the location where the proximal taper 140a of the balloon 104 meets the shaft system 102. This marker indicates to the user that the shaft location is 1 cm away from the end of the balloon indicating that the balloon has extended from the guide during the procedure.
- a second distal shaft marker 130 may be disposed on the shaft system 102 such that the distal edge of the marker is 1 cm. ⁇ .0.1 cm from the distal edge of the first distal shaft marker 128. As shown in FIG. 1 , the second distal shaft marker is a double marker to distinguish the first and second distal shaft markers 128 and 130 one from one another.
- the second distal shaft marker 130 indicates the shaft location being 2 cm away from the proximal end of the balloon 104, thus indicating the distance the balloon has extended from the guide during the procedure.
- the two markers forming the second distal shaft marker 130 are each 0.75 mm wide and white in color, however, the size and color of the marker can be changed in alternative embodiments.
- a third distal shaft marker 129 is disposed adjacent the proximal taper 140a the balloon 104.
- the physician user can identify the length of catheter that has been advanced and retracted out of a guide catheter and/or can approximate a location of the balloon 104 relative to patient anatomy such as a paranasal sinus ostium, other paranasal sinus opening, or other openings in the ear, nose or throat.
- This approximation of balloon position may be very useful in circumstances when the balloon 104 has been advanced far enough into an anatomical location that the balloon 104 can no longer be viewed via endoscope.
- endoscopic markers the user is able to endoscopically gauge the distance the catheter has advanced into the frontal recess once the proximal portion of the balloon is no longer visible.
- distal shaft markers having different numbers, sizes, colors and positions along the catheter shaft may be used.
- FIG. 8 shows a series of sinus guide catheters 200a-200f that may be used in conjunction with the medical device 100.
- These guide catheters 200a-200f are have a substantially rigid proximal section, a less rigid distal and an atraumatic tip, and each has a preset distal curve of approximately 0 degrees (200a), 30 degrees (200b), 90 degrees (200d), 70 degrees (200c) or 110 degrees (200e and 200f).
- the guides may have different diameters in the less rigid distal section such as shown in with regard to guide catheter 200e and 200f. Different curvatures are useable to access the ostia of different sinuses.
- a 70 degree guide is typically used to access the ostium of a frontal sinus
- a 90 or 110 degree guide is typically used to access the ostium of a maxillary sinus
- Each of these guide catheters 200a-200f has an axial length of about 12.7 cm.
- These sinus guide catheters are described in U.S. patent application Ser. Nos. 10/944,270 and 11/355,512 and U.S. patent Nos. 7,654,997 and 7,803,150 which are hereby incorporated by reference, and are commercially available as RelievaTM sinus guide catheters from Acclarent, Inc., Menlo Park, Calif.
- Sinus access is achieved by positioning the sinus guide catheter 200a in the nasal anatomy, and advancing the sinus guidewire or sinus illumination system into the target sinus. Once sinus access has been achieved, the balloon dilation catheter 100 is advanced over the sinus guidewire or sinus illumination system and into the target space. The endoscopic markers on the balloon catheter can be used to assist with placement. The balloon dilation catheter 100 is then inflated to dilate the sinus ostia. Following dilation, the balloon is deflated. The guidewire or sinus illumination system is removed from the nasal anatomy followed by removal of the balloon dilation catheter 100 and sinus guide catheter 200a. The balloon dilation catheter 100 can be prepared for additional sinus dilations in the same patient.
- FIG. 9 shows an alternate device with which the balloon catheter of the current invention may be used.
- the medical device 600 includes a guide catheter 602, a guide wire 604, the balloon catheter 100 described herein with an attached balloon catheter movement mechanism 134, a guidewire movement mechanism 608 and a suction pathway 612.
- the balloon catheter movement mechanism 134 is configured for advancement and retraction of the balloon catheter 100 through the handle 614 and guide catheter 602 by user operation of the balloon catheter movement mechanism 134 using a thumb or single finger.
- the handle 614 is ergonomically designed such that the finger anchoring pegs 616a, 616b, and 616c can be placed between the fingers of either a right handed or left handed user to provide for support of the device 600.
- the locking tab 618 prevents the balloon catheter mechanism 134 from moving proximally when it is in the up position, but allows for movement distally. When the locking tab 618 is in the down position, the balloon catheter 100 and guidewire 604 can be inserted into the handle through the guide catheter 602.
- the balloon dilation catheter 100 sizes may be 5mm x16mm, 6mm x 16mm and 7mm x16mm, or they may be 3.5mm x 12mm, 6mm x 16mm or 7mm x 24mm, although others are within the scope of the invention, including, but not limited to 5mm x 16mm, 5mm x 24mm or 7mm x 16mm.
- the balloon inflated diameters for the medical devices are as follows: 3.5 mm for the 3.5mm x 12mm, 5mm for the 5mm x16mm and the 5mm x 24mm, 6 mm for the 6mm x 16mm and 6mm x 24mm, and 7 mm for the 7mm x 24mm.
- the balloon 104 is made of any suitable material know in the art for inflation balloons and may be constructed or semi-compliant of non-compliant materials such as nylon (semi-compliant) and polyethylene terepththalate (PET) (non-compliant).
- the balloon is constructed of nylon.
- the atraumatic tip portion 106 is made of a softer material (of lower durometer, i.e. of between about 20D and 55D than the remainder of the balloon catheter and may be made of nylon, pebax or a compound mixture of these materials.
- the atraumatic tip may be constructed of smaller diameter material (less than about 2.0 mm in diameter, often less than about 1.5 mm in diameter) to ensure it is soft and atraumatic.
- the tip is approximately 1 mm in length and may contain a 0.5% to 5% colorant for visual or endoscopic visualization and 20% barium sulfate as a radiopaque marker for fluoroscopic visualization in the patient anatomy.
- the hypotube shaft 116 may be constructed of materials including but not limited to stainless steel and nitinol, and is often is constructed of 304 stainless steel. The combination of materials and catheter construction (the nylon balloon, the soft, atraumatic tip 106 and the adjacent dual lumen design) provides for ease of insertion of the balloon dilation catheter 100 into and removal from the guide catheter 200a or the medical device 600 and navigation through the tortuous sinus anatomy.
- FIG. 26 shows a medical device 2600 according to the invention that includes a guide catheter 2602, a guiding element 2604, in this case an illuminating guidewire, a balloon catheter 2606 with an attached balloon catheter movement mechanism 2608, and a guiding element movement mechanism 2610, and a suction pathway 2612.
- the guiding element movement mechanism 2610 is configured for advancement, retraction and rotation of the guiding element 2604 and the balloon catheter movement mechanism 2608 is configured for advancement and retraction of the balloon catheter 2606 using a thumb or single finger.
- the handle 2614 is ergonomically designed such that the finger anchoring pegs 2616a, 2616b, 2626c and 2616d can be placed between the fingers of either a right handed or left handed user to provide for support of the device 2600.
- FIG. 10 shows an alternative lumen design and balloon catheter tip configuration for the device shown in FIGs. 3 and 26 such that irrigation of the sinuses can be accomplished either before or after dilation of the sinus ostia using a single-handed system that need not be removed from the sinus in between procedures.
- the cut-out portion 146 of the hypotube 116 from the balloon dilation catheter 100 has an altered integrated shaft system 1000 that includes an irrigation lumen 1002 (see FIG. 10).
- the inflation lumen 1020 extends the length of the integrated shaft system 1000 from the proximal most end to the balloon 104 and provides for inflation of the balloon 104 for dilation of the sinus ostium. As shown in FIG.
- the distal portion 1022 of the integrated shaft system 1000 includes a combined lumen 1004 (a combined lumen for irrigation and for containing the guiding element 1008).
- the proximal portion 1024 of the integrated shaft system 1000 includes a guiding element lumen 1006 and an irrigation lumen 1002 in side by side arrangement.
- the integrated shaft system 1000 provides for the flow of irrigation liquid from an irrigation port (a luer connector) added to the proximal end of balloon catheter 100 to junction 1010 where it enters the combined lumen 1004.
- the irrigation liquid exits from the balloon catheter through irrigation apertures (see for example irrigation apertures 1530 in FIG. 15 at the distal end of the balloon catheter 1500 distal to the balloon 1516).
- a plug 1012 is incorporated into the guiding element lumen 1006 to seal off the guiding element lumen 1006 such that when the guiding element 1008 is retracted proximally (in the direction of arrow 1014) to the junction 1010 of the distal end 1016 of the irrigation lumen 1002 and the proximal end of the combined lumen 1004, the guiding element lumen 1006 will be sealed between the stopper 1018 that is attached to the guiding element 1008 (in this case a ring of solder, a thin hypotube or an over-lamination of plastic) and the plug 1012.
- the irrigation fluid will flow to the balloon distal end rather than out of the cut-out portion 146 of the hypotube 116.
- the guiding element seal area of the guiding element lumen 1006 may be dimensioned to be close to the outer diameter of the guiding element 1008, such that any flow of irrigation fluid through the cut-out portion 145 of the hypotube 116 would be minimal (less than 10%), and the majority (90% or greater) would flow to the balloon distal end.
- FIG. 11 shows an alternative design for the balloon catheter movement mechanism 134 and the guiding element movement mechanism 608 shown in FIG. 9 in order to accommodate the irrigation lumen described above with regard to FIG. 10.
- the balloon catheter movement mechanism 1102 and the guiding element movement mechanism 1104 are not co-linear, that is, they are not shown one behind the other but rather are shown next to each other (although they could be one on top of the other) to allow for proximal movement of the guiding element 1110 out of the irrigation pathway such that irrigation can occur without removal of the device 1100 from the sinus anatomy following treatment (such as balloon dilation) and reinsertion for purposes of irrigation.
- the balloon catheter movement mechanism 1102 wraps around the balloon shaft 1112, and the mechanisms 1102 and 1104 are shaped and positioned to easily slide past each other without inhibition.
- FIG. 12 shows the medical device 1100 of the current invention for dilation and irrigation of the sinus ostium.
- the balloon catheter movement mechanism 1102 and guiding element movement mechanism 1104 are side by side. This configuration occurs when the user is advancing the balloon catheter 100 into the sinus or retracting the guiding element tip 106 into the device 1000.
- the guiding element movement mechanism 1104 may be connected to the guiding element 1110 by a spring overload mechanism to provide enough force to set the guiding element tip 106 without damaging it.
- the proximal nub 1106 on the guiding element movement mechanism 1104 allows the user to pull the guiding element movement mechanism 1104 proximally or push it distally when the guiding element movement mechanism 1104 is next to the balloon catheter movement mechanism 110, especially for a user who holds the device 1000 with the guiding element movement mechanism 1104 away from or in the case of a left-handed person, when holding the device 1000 with the guiding element movement mechanism 1104 opposite them. From this configuration, the balloon catheter movement mechanism 1102 can be moved proximally such that it is behind the guiding element movement mechanism 1104 (as shown in FIG. 13). This will occur when the guiding element 1110 is being inserted into the sinus cavity prior to advancement of the balloon 1516 (see FIG. 15) into the ostium.
- the guiding element 1110 can be retracted such that the guiding element 1110 is removed from the sinus prior to irrigation.
- the guiding element movement mechanism 1104 would therefore be behind the balloon catheter movement mechanism 1102 as shown in FIG. 14.
- FIGs.14A, 14B and 14C Alternative configurations for locating the balloon catheter movement mechanism 1102 and guiding element movement mechanism 1104 are shown in FIGs.14A, 14B and 14C.
- distal movement of the mechanisms is shown by arrow 1400.
- the balloon catheter movement mechanisms 1404 and 1414 are located at the side of the handle 1406 and the guiding element movement mechanisms 1402 and 1412 are located on top of the handle 1406.
- the balloon catheter movement mechanism 1424 is located on top of the guiding element movement mechanism 1422.
- the mechanisms move independently of each other such that each one can be in front or in back of the other one.
- the guiding element therefore, can be inserted into the sinus anatomy and positioned there for access to the sinus cavity (the target space in the nasal anatomy) and during dilation of the ostium and can be retracted there from for irrigation of the sinus cavity through the balloon catheter 1500.
- the relative geometry of the user interfacing features may be altered such that the two movement mechanisms may be clearly differentiated from one other tactically (for example by size or by position) and not interfere with one another as they pass by each other. This can allow the user to maintain continuous contact with one or the other movement mechanism as desired.
- Spring-loaded detents, friction elements or magnets may be used to hold the mechanisms in place.
- a passively activated positive locking latch that would require a different action for release, such as a user operated release button or an automatic release activated by sliding the mechanisms to certain positions within the handle could be employed to lock the mechanisms and thus the balloon 104 and/or the guiding element 604 in place relative to each other and/or the handle 614.
- FIGs. 15 and 16 show a further alternative catheter for dilation and irrigation of the sinus anatomy.
- the proximal end 1502 of the integrated shaft system 1504 of the balloon dilation catheter 1500 includes three lumens as shown in FIG. 17A, an irrigation lumen 1506, a guiding element lumen 1508 and an inflation lumen 1510.
- the lumens are all side by side lumens.
- the guiding element lumen 1508 and the irrigation lumen 1506 are combined into a combination lumen 1518.
- the proximal end 1520 of the guiding element tip 1522 of guiding element 1524 is shown located at the juncture 1526 between the combination lumen 1518 and the guiding element lumen 1524 and irrigation lumen 1506.
- the guiding element 1524 is retracted proximally to the position shown in FIGs. 15 and 16 such that the proximal end 1520 of the guiding element tip 1522 is seated against the juncture 1526, thereby effectively sealing the guiding element lumen 1508 and preventing flow of irrigation liquid into the guiding element lumen 1508 and out of the cut-out portion 146 of the hypotube 116 shown in FIG.
- the guiding element tip 1522 may be spring loaded to provide the seating force, rather than relying upon the user keeping tension on it.
- the irrigation apertures 1530 are between about 0.020 inches and about 0.050 inches and there may be any number of apertures between about 1 and 10 apertures, usually between about 2 and 5 apertures, and often 3 apertures.
- the embodiment shown in FIG. 15 includes a forward facing tip opening 1531 and three radially facing openings 1530, on irrigation tip 106 spaced 120 degrees apart, with the inner diameter of the forward facing tip opening being 0.037 inches and each of the side openings having a inner diameter of 0.026 inches and the inner diameter of the irrigation lumen proximal of the atraumatic tip is about 0.042 inches.
- Alternative embodiments may include any suitable alternative number of side openings distributed in any suitable pattern such as a helical pattern.
- a first side opening may be placed at about 2.5 mm from the distal end of medical device 100
- a second side opening may be placed at about 3.5 mm from the distal end of medical device 100
- a third side opening may be placed at about 4.5 mm from the distal end of medical device 100, with each of these measurements being from the distal end to approximately the center of each side opening.
- the length of the irrigation tip from the distal end of the medical device 100 to the distal end of the balloon 104 is approximately 7 mm.
- Each side opening may have any suitable diameter in various alternative embodiments.
- each side opening may have a diameter of between about 0.020 inches and about 0.050 inches and or between about 0.030 inches and about 0.040 inches and or about 0.033 inches, so long as the diameter of the irrigation lumen of the irrigation tip proximal of the atraumatic tip 106 is larger than the diameter of the forward facing tip opening.
- the length of the balloon dilation catheter distal tip from the distal end of the balloon 1516 to the distal end of the balloon dilation catheter 1500 is between about 5 mm and 10 mm often about 7mm.
- FIG. 17 shows an alternative to the device shown in FIGs. 15 and 16.
- a plug 1528 is included on the guiding element 1524, in this case a hypotube welded onto the coil of the guiding element 1524 to aid in sealing the guiding element lumen 1508 at the juncture 1526 and prevent flow of irrigation liquid into the guiding element lumen 1508 and out of the cut-out portion 146 of the hypotube 116, when the guiding element is retracted during irrigation.
- FIGs. 24A, B, C, D, E and F are alternative designs for the balloon catheter assembly 2400 according to the invention.
- the balloon catheter assembly shown in FIG. 24A has a mid-catheter joint 2402 that is further shown in FIG. 24E.
- the balloon catheter assembly has an inflation port 2404, an irrigation port 2406 and cut- out portion 2408 for insertion of the guiding element (not shown).
- the assembly 2400 has a proximal section 2410, a middle section 2412 and a distal section 2414.
- a cross-section of the catheter shaft 2416 in the proximal section 2410 is shown in FIG. 24B.
- the catheter shaft 2416 includes an irrigation tube 2418, an irrigation lumen 2420, an inflation tube 2422 and an inflation lumen 2424 in co-axial arrangement.
- a cross-section of the catheter shaft 2416 in the middle section 2412, proximal to the mid-catheter joint 2408 is shown in FIG. 24C.
- An inflation tube 2426 and an inflation lumen 2428 remain in coaxial arrangement with the irrigation tube 2430 and irrigation lumen 2432.
- a sleeve 2434 (in this case a hypotube) is in coaxial arrangement with the irrigation tube 2430, but an opening 2436 in the sleeve 2434 allows for insertion of the guiding element (not shown).
- a cross-section of the catheter shaft 2416 in the distal section 2414 is shown in FIG. 24D.
- This distal catheter shaft 2438 includes side by side lumens, an inflation lumen 2440 and an irrigation and guiding element lumen 2442.
- the mid-catheter joint 2408 is further shown in FIG. 24E.
- a cross-section of the catheter shaft 2416 in the proximal portion 2450 of the mid-catheter joint 2408 is shown in FIG. 24F and a cross-section of the catheter shaft 2416 in the distal portion 2452 of the mid-catheter joint 2408 is shown in FIG. 24G.
- a inflation tube 2454 with an inflation lumen 2456 is coaxially within an irrigation tube 2458 with an irrigation lumen 2460.
- a guiding element lumen 2464 In side by side arrangement is a guiding element lumen 2464.
- a hypotube 2466 surrounds both the guiding element lumen 2464 and the irrigation tube 2458.
- the coupler 2470 is a tube that bridges across the mid-catheter joint 2408 from its distal end 2452 to its proximal end 2450. As shown in FIG. 24G, the coupler 2470 surrounds the inflation lumen 2472 and the guiding element lumen 2464 and irrigation lumen 2474 which are in side by side arrangement.
- the transition section 2480 between the proximal portion 2450 and distal portion 2452 provides for the combination of the guiding element lumen 2464 and the irrigation lumen 2460 of the proximal portion 2450 into the combination of the guiding element and irrigation lumen 2474 of the distal portion 2452.
- a liner (often polymeric and often a PTFE liner) may be included inside the combination lumen 2474 such that when the balloon catheter 2400 is placed within an angled guide catheter (such as shown in Fig. 8), the combined irrigation and guiding element tube 2476 will provide lubricity and kink resistance for the advancement, retraction and rotation of the guiding element .
- FIGs. 25A and 25B are alternative cross-sectional designs for the proximal portion shown in FIG 24F of the catheter assembly 2400.
- the guiding element lumen 2516 and the irrigation lumen 2514 remain separate, side by side lumens and are further in side by side arrangement with the guiding element lumen 2516.
- the proximal portion shown in FIG. 25A includes an inflation lumen 2502 and an irrigation lumen 2504 in side by side arrangement.
- distal movement of the mechanisms is shown by arrow 1400.
- the balloon catheter movement mechanism 1804 is a rotating thumbwheel that is fixed to the handle 1806.
- the balloon catheter movement mechanism 1804 drives the balloon catheter through a belt 1808 or counter wrapped string drive attached to a balloon carriage 1810.
- Alternative methods for driving the balloon include a rack and pinion, other types of gear and shaft systems, a rotating leadscrew type drive or a linear/rotational racheting system with a slider or lever.
- the guiding element movement mechanism 1802 is located on top of the handle 1806.
- the guiding element movement mechanism 1802 slides over the balloon catheter 1812 such that the guiding element and balloon catheter 1812 can be positioned independently.
- An alternate version of the embodiment shown in FIGs. 18A and 18B contemplates a slider for the balloon catheter movement mechanism and a fixed thumbwheel or roller for the guiding element movement mechanism.
- the guiding element movement mechanism 1902 and the balloon catheter movement mechanism 1904 appear to the user as two separate slider mechanisms that are coaxial in the same track.
- the balloon catheter movement mechanism 1904 is a coupled to a balloon catheter carriage 1910, the balloon catheter movement mechanism 1904 being separable from the balloon catheter carriage 1910.
- the balloon catheter balloon carriage 1910 is attached to the balloon catheter 1912.
- the balloon catheter movement mechanism 1904 is coupled to the balloon catheter carriage 1910 as the balloon catheter 1912 is positioned within the sinus anatomy. Once the balloon catheter carriage 1910 is positioned as shown in FIG.
- the balloon catheter movement mechanism 1904 can be decoupled from the balloon carriage 1910 and moved proximally away from the balloon carriage 1910, thus allowing the guiding element movement mechanism 1902 to slide proximally past the balloon catheter carriage 1910 to move the guiding element out of the irrigation pathway as described previously.
- the de-coupling of the balloon catheter movement mechanism 1904 from the balloon carriage 1910 can be accomplished by the user, for instance by pushing a spring loaded button 1920 such that the balloon catheter movement mechanism 1904 and the balloon carriage 1910 can separate.
- the user can flip a two-state (bi-stable) toggle or button to an unlocked position such that the balloon catheter movement mechanism 1904 and the balloon carriage 1910 can separate.
- Re-coupling of the balloon catheter mechanism to the balloon carriage can be accomplished actively, for example, by the user pushing the button to a different state, or passively, for example where the balloon catheter mechanism automatically reattaches with a spring loaded lock as it slides over the carriage.
- Alternative designs for this embodiment would include a guiding element movement mechanism that is not attached to the guiding element, but that is attached to a guiding element carriage such that the guiding element movement mechanism and guiding element carriage could be detached one from the other through user activation of a spring loaded button, or a single external mechanism for both the balloon catheter and the guiding element that could engage and couple and decouple with either the guiding element or the balloon catheter through a user activated push button mechanism or other action.
- FIGs. 20A and 20B show the design of a handle 2006 for a medical device 600 where a guiding element movement slider mechanism 2002 is used to move a guiding element but the balloon catheter movement mechanism is replaced with a motor 2004 that is controlled through switches.
- the switches shown in FIGs. 20A and 20B are push buttons 2008a and 2008b, but could also be rocker type or other switches known in the art. These switches could incorporate variable speed. Since there is no external movable control for the balloon catheter (not shown), the guiding element movement mechanism 2002 can pass freely above and proximal to the balloon carriage 2010.
- the motor can drive the balloon catheter through a balloon drive leadscrew as shown in FIG. 20B or another arrangement such as a rack and pinion, belt drive or other transmission type known in the art.
- the motor 2004 may be electrically powered through either a battery or external power source, or may be a pneumatically driven motor running off of a suction pump or hydraulically driven such as an irrigation pump.
- the guiding element movement mechanism 2102 is located on top of the handle 2106 and the balloon catheter movement mechanism 2104 is located on the bottom the handle 2106.
- the location of the guiding element movement mechanism 2102 and the balloon catheter movement mechanism 2104 could be reversed such that the guiding element movement mechanism 2102 is on the bottom and the balloon catheter movement mechanism 2104 is on the top. In either case, the mechanisms move independently of each other such that each one can be in front or in back of the other one.
- the guiding element therefore, can be inserted into the sinus anatomy and positioned there for access to the sinus cavity (the target space in the nasal anatomy) and during dilation of the ostium and can be easily retracted therefrom by the use of easily operated handle control for irrigation of the sinus cavity through the balloon catheter without removing the medical device 600 from the surgical field or without requiring addition personnel to aid in retraction of the guiding element.
- the guiding element movement mechanism 2202 and the balloon catheter movement mechanism 2204 are coaxial in the same track.
- the guiding element 2224 is holding in a spring 2226 in a compressed state in the guiding element movement mechanism 2202 during positioning of the guiding element 2224 and the balloon catheter (not shown).
- the guiding element 2224 When irrigation is desired, the guiding element 2224 is released from the guiding element movement mechanism (see FIG. 22C) through a clamp release or button that decompresses the spring 2226. The guiding element 2224 becomes loose in the guiding element movement mechanism 2202 and automatically moves proximally out of the irrigation pathway. After the spring has been deployed
- the guiding element and spring would need to be reset (the spring must be re-compressed). This may be accomplished by pulling on the guiding element in the direction of arrow 1400, a user activated plunger type mechanism to recompress the spring from the proximal side, or a spring reset-mechanism incorporated into the handle or around the guiding element.
- the guiding element movement mechanism 2302 has a tunnel 2310 and the protrusions 2312 of the balloon catheter movement mechanism 2304 are small enough to pass underneath the guiding element movement mechanism 2302.
- the guiding element movement mechanism 2302 can pass over the balloon catheter movement mechanism 2304 for retraction of the guiding element and consequent use of irrigation.
- the user can maintain continuous contact with the guiding element movement mechanism 2302 as the guiding element is retracted and movement of the fingers is not required in order for the guiding element movement mechanism 2302 to move distal to the balloon catheter movement mechanism 2304. It may be desirable to use an endoscope in conjunction with the device 600 or device 1100 of the invention, for visualization of the treated region.
- a rotational and articulating element such as a ball and socket is inserted between the handle 614 and the guide catheter 602 shown in Fig. 9.
- the element may be adjustable within a given range of rotation and bend angles or may have discrete position, dictated by the user either prior to or during the method of the invention.
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Abstract
Description
Claims
Applications Claiming Priority (5)
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US201261698040P | 2012-09-07 | 2012-09-07 | |
US13/827,593 US9579448B2 (en) | 2012-04-13 | 2013-03-14 | Balloon dilation catheter system for treatment and irrigation of the sinuses |
PCT/US2013/036362 WO2013155409A1 (en) | 2012-04-13 | 2013-04-12 | Balloon dilation catheter system for treatment and irrigation of the sinuses |
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EP2836138A1 true EP2836138A1 (en) | 2015-02-18 |
EP2836138B1 EP2836138B1 (en) | 2019-06-12 |
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EP13718974.2A Active EP2836138B1 (en) | 2012-04-13 | 2013-04-12 | Balloon dilation catheter system for treatment and irrigation of the sinuses |
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US (5) | US9579448B2 (en) |
EP (1) | EP2836138B1 (en) |
JP (2) | JP6612125B2 (en) |
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-
2013
- 2013-03-14 US US13/827,593 patent/US9579448B2/en active Active
- 2013-04-12 AU AU2013245790A patent/AU2013245790A1/en not_active Abandoned
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- 2013-04-12 CN CN201380019695.1A patent/CN104220015B/en not_active Expired - Fee Related
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- 2013-04-12 WO PCT/US2013/036362 patent/WO2013155409A1/en active Application Filing
- 2013-04-12 CA CA2870282A patent/CA2870282A1/en not_active Abandoned
- 2013-04-12 IN IN8038DEN2014 patent/IN2014DN08038A/en unknown
- 2013-04-12 JP JP2015505941A patent/JP6612125B2/en not_active Expired - Fee Related
- 2013-04-12 RU RU2014145533A patent/RU2014145533A/en not_active Application Discontinuation
- 2013-04-12 EP EP13718974.2A patent/EP2836138B1/en active Active
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2017
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2018
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2020
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2021
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Publication number | Priority date | Publication date | Assignee | Title |
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WO2020146809A1 (en) * | 2019-01-11 | 2020-07-16 | Medtronic Xomed, Inc. | Sinus dilation |
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US11844539B2 (en) | 2023-12-19 |
US10905820B2 (en) | 2021-02-02 |
EP2836138B1 (en) | 2019-06-12 |
US9579448B2 (en) | 2017-02-28 |
AU2013245790A1 (en) | 2014-11-20 |
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US20240041486A1 (en) | 2024-02-08 |
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US20170128661A1 (en) | 2017-05-11 |
US20140107427A1 (en) | 2014-04-17 |
CN104220015A (en) | 2014-12-17 |
MX2014012375A (en) | 2014-11-25 |
KR20140143842A (en) | 2014-12-17 |
CA2870282A1 (en) | 2013-10-17 |
JP6612125B2 (en) | 2019-11-27 |
RU2014145533A (en) | 2016-06-10 |
US11167080B2 (en) | 2021-11-09 |
CN104220015B (en) | 2018-09-28 |
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